Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 3, 2019
August 1, 2019
3.6 years
December 12, 2016
August 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Montgomery-Åsberg Depression Rating Scale (MADRS)
1 week
Secondary Outcomes (2)
Clinician Administered Dissociative States Scale (CADSS)
2 weeks
Hamilton Depression Rating Scale
1 week
Study Arms (2)
Ketamine treatment group
ACTIVE COMPARATOREach patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.
Control group
ACTIVE COMPARATOREach patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
- Hamilton depression rating scale score ≥ 19
- Willingness and competence to sign the informed consent form
- Stable psychopharmacological treatment for 10 days (except benzodiazepines)
You may not qualify if:
- Prior use of ketamine
- Pregnancy/Breast feeding
- Instable arterial hypertension \>170/110mmHg
- Hepatic dysfunction
- Hyperthyreosis
- History of glaucoma
- Neurodegenerative disorders
- Any unstable medical illness
- History of substance abuse within the past 12 months
- History of psychosis
- Failure to comply with the study protocol or to follow the instructions of the investigating team
- Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.-Prof., MD PD
Study Record Dates
First Submitted
December 12, 2016
First Posted
December 14, 2016
Study Start
April 24, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
September 3, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share